Baseline Sleep Apnea Study #2

Not Applicable

Completed

Brief Summary: This is a single group, unblinded, prospective clinical study. This study seeks to understand patient diagnostic and treatment journey and positive airway pressure (PAP) therapy compliance for Verily Sleep Apnea (VSA) program/app users. Participants will enroll remotely and may undergo a home sleep test (HST). Upon confirmation of obstructive sleep apnea (OSA) and prescription of PAP therapy, the participant will begin using the VSA app to supplement PAP treatment. After 90 days of active participation, the participant will be given instructions for follow-up care, as indicated.

Recruitment & Eligibility

Inclusion Criteria

Ages 18 or older
Able to speak and read English
Legal United States Resident with a Government Issued ID
Participating in the Project Baseline Community Study
Demonstrates understanding of the study requirements and is able and willing to sign the informed consent form
Own a smartphone with a data plan and be the primary user of the smartphone; smartphone must use Android Lollipop (5.1+/ API 22+) or iOS 11.X+
Own a computer with a web camera
Consistent access to electricity and wifi for the duration of the study
Have a high risk of OSA as determined by screening questionnaire
Good candidate for PAP therapy, in the opinion of the managing clinician
Without significant limitation in ability to participate in the study, in the opinion of the investigator.

Exclusion Criteria

Previously diagnosed with sleep apnea or other sleep disorders, that in the opinion of the investigator, makes the participant ineligible (e.g., Obstructive Sleep Apnea, Central Sleep Apnea, Complex Sleep Apnea, chronic insomnia)
Participant is a shift worker (indicated by having a night shift schedule on a regular basis, or a work shift that changes or rotates on a daily, weekly, or monthly basis)
Sponsor employees and individuals working on Project Baseline
Self reported to be pregnant or planning to become pregnant during the study period
Current use of home oxygenation devices, such as supplemental oxygen

Arm && Interventions

Group	Intervention	Description
Arm 1	Verily Sleep Apnea (VSA) Program/App	Participants told they may have Obstructive Sleep Apnea (OSA) and provided a home sleep test (HST)

Primary Outcome Measures

Name	Time	Method
Time (Number of Days) From Therapy Initiation to When 90-day Compliance Threshold is Achieved	90 Days	Time (number of days) from therapy initiation to when 90-day compliance threshold is achieved. 90-day Compliance is defined as ≥ 4 hours per night on 70% of nights during a consecutive 30 day period anytime during the first 90 days.
Time (Number of Days) From When Participant Receives HST Prescription to When They Receive Their Diagnosis	164 days	Time from when the participant receives HST prescription to OSA diagnosis.
Time (Number of Days) From OSA Diagnosis to PAP Therapy Initiation	153 Days	Time from OSA diagnosis to PAP therapy initiation.
Time (Number of Days) From When Participant is Told They May Have OSA to When They Receive HST Prescription	147 Days	Time (number of days) from when participant is told they may have OSA to when they receive HST prescription

Secondary Outcome Measures

Name	Time	Method
Completion Rates Among Individuals Prescribed a PAP Device	90 Days	Percentage of individuals who used the PAP device at least once during the 90 days
Percent of Participants Who Meet 90 Day Compliance Success Criteria	90 Days	Compliance Metrics - Percent of participants who meet 90 day compliance success criteria, as defined by: ≥ 4 hours per night on 70% of nights during a consecutive 30 day period anytime during the first 90 days
Completion Rates Among Individuals Who Had an HST Ordered	161 Days	Among individuals prescribed a HST, % of individuals who completed the HST and had interpretable results.